This position is responsible for providing dedicated support to Operations to develop and maintain those areas of the quality management system in accordance with ISO standards, Good Manufacturing Practices (GMP), Stryker Corporate requirements, and Canadian regulatory requirements. This individual is responsible to support and ensure that effective and efficient quality practices are maintained in collaboration with Global Logistics & Operations (GLO). This individual must serve as a contributing member of the Quality Assurance team while championing Stryker's Mission and Values.ResponsibilitiesIndividual ResponsibilitiesProactively collaborates with internal and external stakeholders to promote a culture of inclusiveness and cooperationResponsible to live and exemplify Stryker's Values: Integrity, Accountability, People, and PerformanceFunctional ResponsibilitiesAct as the key contact for Quality related activities within Operations for Stryker CanadaIdentify improvements and inputs into the quality planning processRepresent QA and act as the QA stakeholder on Operations-led projectsResponsible for the review of programs and/or processes impacting the Quality Management System governing the distribution of regulated products within CanadaIdentify and implement improvement opportunities to increase the efficiency and effectiveness of QMS related documents for OperationsEnsure quality records are established and maintained to provide evidence that the QMS is being followedImplement and maintain the Validation Program in collaboration with Operations and GLO for Stryker CanadaProvide oversight for the development and/or execution of plans, protocols, reporting, training and quality system documents associated with validation requirementsResponsible for the support and review of NCs and CAPAs for Operations, with attention to detail, review for completeness of actions and records, accuracy, and effectivity, and timelinesFacilitate Operations teams in the application of problem-solving techniques and promote its uses and development (e.G. 5 Why's, fishbone diagrams, 4D's, process mapping, etc.)Support the creation of quality objectives/KPI's for Operations, and provide support in meeting requirements/targetsDrive Good Manufacturing Practices and Valuable Documentation Practices within OperationsOther duties as assigned by ManagerConduct & ComplianceAbide by and support the policies set forth in the Stryker Code of ConductUnderstand that compliance with the Code of Conduct, as it may be amended by Stryker Corporation from time to time, is a condition of continued employment with StrykerConduct work in compliance with all laws, rules, and regulations and in accordance with Stryker's high ethical standardsReport any violations of these policies and procedures to Stryker management or in the manner outlined in Stryker's Ethics Hotline PolicyKnowledge & Skill RequirementsWorking knowledge of ISO 9001 requirementsWorking knowledge of Canadian regulations for medical devices, CTO (cells, tissues,



and organs), drugs, natural health products, and cosmeticsStrong computer skills (Excel, Word, Power Point, SharePoint), Trackwise and ComplianceWire will be considered an assetHigh standard of integrity and ability to meet deadlinesHighly organized and able to prioritize tasksProject management and report writing; preferableStrong oral and written communication skills with both internal and external contactsEducation & QualificationsUniversity degree in Science, Engineering or related field requiredPost-graduate diploma in Regulatory Affairs or Quality Assurance preferredMinimum 3+ years' experience in regulatory affairs and/or quality assuranceMedical Device and/or Pharmaceutical experience is an assetInternal applicants with an equivalent combination of education, experience and performance over time at Stryker will be consideredCanada Pay RangesCanada: $72,400 - $96,600 CAD AnnualStryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

📌 Senior Specialist, Operations Quality (Hamilton)
🏢 Stryker
📍 Hamilton